Email this article The development of an algorithm for introduction of a new drug on the existing pharmaceutical production. Stage 2. Transfer of technologies
- Authors: Basevich A.V.1, Dzjuba A.S.2, Kaukhova I.E.1, Tretyakova A.E.1, Sakharov V.A.1
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Affiliations:
- Saint Petersburg State Chemical and Pharmaceutical University
- JSC “PharmProject”
- Issue: Vol 3, No 1 (2021)
- Pages: 18-30
- Section: Pharmaceutical Sciences
- URL: https://journals.rcsi.science/PharmForm/article/view/48535
- DOI: https://doi.org/10.17816/phf48535
- ID: 48535
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Abstract
The paper presents the results of the study based on the guidelines and scientific data on the technology transfer in the circulation of drugs. The initial data for calculations, assessment and analysis of the study results were taken from the current documentation at the operating production site of the pharmaceutical manufacturer with the participation of the company officials. The data was collected from the company work papers and job descriptions following interviews with a group of unit staff involved in the technology transfer.
The summary and the analysis of the data obtained during the research on the technology transfer for the preparation of new drugs were implemented. It was used to construct Gantt charts for some critical processes. Theassessment of the criticality of individual stages of technology transfer and a control chart of the project manager, indicating the control points of this process, was presented.
Hence, the original action plan for the new drug preparation by a pharmaceutical manufacturer has been developed: risk control and assessment system for the technology transfer project activities has been determined to assess the degree of criticality of deviations, both for the individual stages and the entire technology transfer project.
According to the objectives of the study, an original action plan for the new drug preparation by the pharmaceutical manufacturer based on the collection, processing and analysis of the data on the technology transfer at the manufacturing site has been developed.
If required, the original action plan may be tested by other drug manufacturers in the pharmaceutical industry.
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##article.viewOnOriginalSite##About the authors
Anna V. Basevich
Saint Petersburg State Chemical and Pharmaceutical University
Author for correspondence.
Email: anna.basevich@pharminnotech.com
SPIN-code: 8189-3806
D. in Pharmaceutical Sciences, Associate Professor at the Industrial Technology of Medicines Department, Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation, Saint PetersburgAnatoliy S. Dzjuba
JSC “PharmProject”
Email: anatoly.dzuba@pharminnotech.com
Ph.D. in Pharmaceutical Sciences, Head of the Development Department, JSC “PharmProject”
Russian Federation, Saint PetersburgIrina E. Kaukhova
Saint Petersburg State Chemical and Pharmaceutical University
Email: irina.kaukhova@pharminnotech.com
SPIN-code: 2931-5790
Scopus Author ID: 736701
D.Sc. in Pharmaceutical Sciences, Professor, Head of the Industrial Technology of Medicines Department, Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation, Saint PetersburgArina E. Tretyakova
Saint Petersburg State Chemical and Pharmaceutical University
Email: arina.tretjakova@pharminnotech.com
Master Student of the faculty of Industrial Medicine Technology, Department of Economics and Management, Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation, Saint PetersburgVitaly A. Sakharov
Saint Petersburg State Chemical and Pharmaceutical University
Email: vitalij.saharov@spcpu.ru
Master Student of the faculty of Industrial Medicine Technology, Department of Industrial Ecology, Saint Petersburg State Chemical and Pharmaceutical University
Russian Federation, Saint PetersburgReferences
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